FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
70518-4084
11-digit product format
705184084
Labeler code
70518
Product ID
70518-4084_47676b70-4de2-8f01-e063-6394a90a4a18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215630
Marketing category
ANDA
Marketing start
2024-05-17
Substance
FAMOTIDINE
Active strength
40 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FAMOTIDINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4084-0FAMOTIDINE30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-4084-1FAMOTIDINE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED907
70518-4084-2FAMOTIDINE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4084FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 3 package rows20240522_9c5dce17-1865-4aa6-89f6-24dd55b5f06c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN9c5dce17-1865-4aa6-89f6-24dd55b5f06c7
284245famotidine 40 MG Oral TabletSCD9c5dce17-1865-4aa6-89f6-24dd55b5f06c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4084-07051840840030 in 1 BLISTER PACKHistorical
70518-4084-17051840840190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-1) 2025-05-29NoNoHistorical
70518-4084-27051840840230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-2) 2025-10-12NoNoHistorical